BusinessWeek JUNE 13, 2005 COVER STORY
Biotech, Finally
Yes, the business remains risky, but medical progress is stunning.
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Julia Barchitta's main physical complaint these days is blisters on her feet. That's pretty remarkable, considering she has been living for three years with metastatic kidney cancer -- a notoriously hard-to-treat disease. Until May, 2004, the 61-year-old dean of the Center for Career Development & Experiential Learning at Wagner College in New York was lucky enough to respond to interferon, a drug that works for only 10% to 20% of patients. But she grew resistant, and the tumors spread throughout her body.
Barchitta knew how tough it can be to beat cancer. Shortly after her own tumor was discovered, her husband was diagnosed with lung cancer and died four months later. So in June, 2004, Barchitta agreed to enter a clinical trial at Memorial Sloan-Kettering Cancer Center for an experimental therapy named Sutent, one of a new class of multitargeted cancer drugs. Sutent was originally discovered by Sugen Inc., an innovative biotech firm that was absorbed into giant Pfizer Inc. (PFE ) in 2002. Barchitta had no hesitation about serving as a guinea pig. "Let's face it, the statistics are not great for kidney cancer," she says. "What did I have to lose?" In fact, she is one of the winners: Sutent eliminated all traces of Barchitta's cancer, and it has yet to recur. The only side effect has been those blisters. "I've learned to wear sneakers to work," she says.
THE POWER TO CHANGE PROGNOSES
Stories like Barchitta's have convinced many doctors that medical care is reaching a tipping point. Not that most patients will be healed right away -- the vast majority of sick people continue to dose themselves with tiny bits of chemicals, otherwise known as pills, that represent medicine's Old Guard. But the times are changing. The past 30 years of biological discoveries, insights into the human genome, and exotic chemical manipulation have unleashed a wave of biological drugs, many of them reengineered human proteins. These molecules have the power to change the prognoses for a huge range of diseases all but untreatable just five years ago. Recent weeks, for example, have seen announcements of startling advances against cancer and age-related blindness, diseases with miserable outlooks before. Cancer patients in particular have reaped rewards from biotech. A decade ago there were fewer than 10 oncology drugs in clinical trials, most of them highly toxic chemotherapies. Today over 400 cancer drugs are being tested in humans, and almost all are targeted biotech medicines designed to produce minimal side effects.
Biotechnology has finally come of age. This declaration may bring to mind the hype that has swirled around biotech so many times in the past. But a growing number of scientists and industry executives say today's enthusiasm is based on a new reality: Drugs actually exist. There are 230 medicines and related products created from biotech techniques. Last year alone, the Food & Drug Administration approved 20 biotech drugs, among them treatments for insomnia, multiple sclerosis, severe pain, chronic kidney disease, incontinence, mouth sores, and cancer. The Tufts Center for the Study of Drug Development estimates that at least 50 of 250 biotech drugs currently in late-stage clinical trials should win FDA approval, a success rate almost three times better than the pharma industry standard. "This is all a continuum of discoveries that started in the early 1980s," says Joseph Schlessinger, chairman of the pharmacology department at Yale School of Medicine and a co-founder of Sugen, the company that created Sutent. "We are now in a golden age of drug discovery."
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Consequently, researchers say it is unlikely that adult stem cells will be sufficient to fulfill the promise of this emerging area. Many are counting on embryonic stem cells. Embryonic stem-cell research is a must. Besides, the ban on federal funding for most embryonic cell research has put a chill on the whole field. "There are a bunch of very talented developmental biologists who could be taking this on," says Jose Cibelli, professor of animal biotechnology at Michigan State University. "But they don't want to touch it."
Some states are trying to go where the federal government refuses to tread. California has pledged $3 billion over 10 years to embryonic stem-cell research. Connecticut lawmakers approved $1 billion. Massachusetts legislators overrode the governor's veto on May 31 to pass a law allowing therapeutic embryo cloning. The science is certain to follow the money. As Wise Young, director of the collaborative neuroscience center at Rutgers University, notes, stem-cell technology "has the chance of being the most important advance to come along in the last 10 years."
It is worth remembering that, 20 years ago, scientists were saying the same thing about biotech advances that looked just as pie-in-the-sky. There has been plenty of hype and plenty of doomsaying in the interim, but the science kept moving ahead. As the many patients who have been helped well know, medicine would be a dreary enterprise if biotech hadn't delivered -- at last.
By Catherine Arnst, with Arlene Weintraub in New York, John Carey in Washington, Kerry Capell in London, and Michael Arndt in Chicago